Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation

Overview[ - collapse ][ - ]

Purpose The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.
ConditionLiver Transplantation
Hepatocellular Carcinoma
Tumor Recurrence and Metastasis
Survival
Adjuvant Chemotherapy
InterventionDrug: gemcitabine and oxaliplatin
Drug: doxorubicin, 5-Fu and cisplatin
PhaseN/A
SponsorShanghai Jiao Tong University School of Medicine
Responsible PartyShanghai Jiao Tong University School of Medicine
ClinicalTrials.gov IdentifierNCT01125020
First ReceivedMay 17, 2010
Last UpdatedMay 17, 2010
Last verifiedMay 2010

Tracking Information[ + expand ][ + ]

First Received DateMay 17, 2010
Last Updated DateMay 17, 2010
Start DateDecember 2008
Estimated Primary Completion DateDecember 2010
Current Primary Outcome Measurestumor recurrence and metastasis [Time Frame: within the first year after liver transplantation] [Designated as safety issue: No]Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy
Current Secondary Outcome MeasuresPostoperative survival [Time Frame: within the first year after liver transplantation] [Designated as safety issue: Yes]Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death.

Descriptive Information[ + expand ][ + ]

Brief TitleImpact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation
Official TitleNot Provided
Brief Summary
The study is designed to investigate the effect of postoperative adjuvant chemotherapy in
prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver
transplantation.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition
  • Liver Transplantation
  • Hepatocellular Carcinoma
  • Tumor Recurrence and Metastasis
  • Survival
  • Adjuvant Chemotherapy
InterventionDrug: gemcitabine and oxaliplatin
Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.
Drug: doxorubicin, 5-Fu and cisplatin
Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.
Study Arm (s)
  • Active Comparator: gemcitabine and oxaliplatin
  • Active Comparator: doxorubicin, 5-Fu and cisplatin

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment150
Estimated Completion DateDecember 2010
Estimated Primary Completion DateMay 2010
Eligibility Criteria
Inclusion Criteria:

- All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and
May 2010 are potentially eligible for enrollment.

Exclusion Criteria:

- Age less than 18 years

- Treatment with other postoperative adjuvant chemotherapy

- Survival is less than 3 months after liver transplantation

- Inability to provide written informed consent prior to study entry
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Jun-Yi Wu, MM
0086-021-63240090
wjy8541@126.com
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT01125020
Other Study ID Numbers2008BAI60B03
Has Data Monitoring CommitteeNot Provided
Information Provided ByShanghai Jiao Tong University School of Medicine
Study SponsorShanghai Jiao Tong University School of Medicine
CollaboratorsShanghai Changzheng Hospital
Investigators Study Chair: Zhi-Hai Peng, MD Shanghai First People's Hospital
Verification DateMay 2010

Locations[ + expand ][ + ]

Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
Contact: Zhi-Hai Peng, MD | 0086-021-632400903132 | pengpzh@hotmail.com
Principal Investigator: Jun-Wei Fan, MD
Recruiting